The Healthy Patterns Sleep Study
Dementia, Alzheimer Disease, Circadian Rhythm Disorders
About this trial
This is an interventional supportive care trial for Dementia focused on measuring Neuropsychiatric Behaviors, Agitation, Alzheimer's Disease, Dementia
Eligibility Criteria
Inclusion criteria for care receiver (CR):
- be over age 60
- English speaking
- be able to tolerate wrist actigraphy (wear a watch on their wrist for a month)
- diagnosed with dementia using standard assessments and diagnostic criteria
- has CG reporting the presence of CRD symptoms
- If the CR is on any of four classes of psychotropic medications (antidepressant, benzodiazepines, antipsychotic, or anti-convulsant) or an anti-dementia medication (memantine or a cholinesterase inhibitor), we will require that the CR have been on a stable dose for 90 days prior to enrollment (typical time frame in clinical trials) to minimize possible confounding effects of concomitant medications
Inclusion criteria for caregiver (CG):
- CG is at least 18 years old
- CG lives close to the participant
- CG is planning to live in the area for at least 6 months
- If CG is on a psychotropic medication, CG must be on a stable dose for at least 60 days
Exclusion criteria for CR:
- deemed to be in a crisis/unsafe situation at baseline
- reported planned transition to another residential or care setting in less than 6 months
- at end-stage disease (defined as bed-bound and noncommunicative, or on hospice at baseline)
- currently enrolled in an interventional clinical trial for dementia or associated symptoms
- regular use of medications with substantial known effects on the measurement of HPA activity (e.g. corticosteroids, interferons, beta-blockers, cytotoxic chemotherapy)
- major surgery in the past 3 months
- history of major psychiatric and/or personality disorder
- history of heavy cigarette smoking (e.g. than 50 pack years)
- loss of a loved one in the past 3 months
- conditions known to affect measurement of circadian rhythm such as use of sedatives/ hypnotics, Huntington's disease, Cushing's disease, Addison's disease, normal pressure hydrocephalus, Parkinson's disease, advanced heart failure (New York Heart Stage 3-4), morbid obesity (BMI 35)
Sites / Locations
- University of Pennsylvania
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Timed Activity Intervention Protocol
Attention-Control Condition
The timed activity group will involve 4 in-home visits and 4 brief telephone education sessions provided over 4 weeks. The timed activity intervention provides activities delivered at specific times in the daily cycle. The in-home sessions are spaced weekly so that the participants can have the opportunity to practice the activity with the interventionist and then on their own. During each session, the interventionist will reinforce activity use, review problem solving approaches, and provide education.
This condition will contain no active elements beyond its nonspecific components, and no theoretical basis to support an effect on CRDs. The attention-control group will also involve 4 in-home visits and 4 brief telephone education sessions. The attention control group will receive printed educational and training materials from the Alzheimer's Association and the NIH on home modification, health promotion, talking to your doctor, and advanced care planning that coincide with session content.